Allysta completes study enrollment for dry eye disease candidate
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The phase 2b/3 OASIS-1 trial of ALY688 ophthalmic solution for the treatment of dry eye disease has completed patient enrollment, according to a press release from Allysta Pharmaceuticals.
The randomized, double-masked, vehicle-controlled study randomized 922 patients with moderate-to-severe dry eye disease based upon signs (staining) and symptoms (patient-reported outcomes) to three potential arms of treatment: ALY688 Ophthalmic Solution (0.4%), ALY688 Ophthalmic Solution (1%), or a vehicle solution.
The assigned treatment will be administered twice daily for 12 weeks.
Allysta anticipates that topline data will be available in the second quarter of 2023, according to the press release.
“We are grateful to the OASIS-1 study investigators, coordinators, and dry eye patients whose dedication and commitment were instrumental in the successful completion of enrollment in this multicenter pivotal study,” Kenneth Sall MD, medical head of ophthalmology at Allysta, said in the release.